Cimetidine Tablets 200mg/400mg THERAPEUTIC CLASS: Antiulcer ants, H2-receptor antagonists (H2RA) COMPOSITION: Cimetidine Tablets B.P. 200mg Cimetidine Tablets B.P. 400mg PHARMACOLOGY: Cimetidine is a histamine H2-antagonist and inhibits actions of histamine mediated by H2 receptors such as gastric acid secretion and pepsin output. INDICATIONS: It is used where inhibition of gastric acid secretion may be beneficial as in peptic ulcer disease, including stress ulceration, duodenal ulcer; benign ulcer recurrent and stomal ulceration, oesophageal reflux disease and other conditions where reduction of gastric acid is beneficial such as persistent, dyspeptic symptoms particularly meal related. CONTRA-INDICATIONS: Hypersensitivity to cimetidine. PRECAUTIONS/WARNINGS: Warning: Use in pregnancy should done with caution, lactating mothers should not take this medication. Precaution: Reduce dose in renal and hepatic impairments, avoid I.V. injection in high dosage and in cardiovascular impairments, pregnancy, breastfeeding. KEEP ALL MEDICINES OUT OF REACH OF CHILDREN. INTERACTIONS: Cimetidine and other 1 - 12-antagonists can reduce the absorption of drugs such as ketoconazole and possibly itraconazole, whose absorption is dependent on an acid gastric pH Cimetidine may inhibit the hepatic metabolism of many drugs by binding to the cytochrome P450 isoenzymes, notably CYP1A2, CYP2C9, CYP2D6 and CYP3A4. Although many such reactions may occur only, a few are considered to be clinically significant, notably those with phenytoin, theophylline, lidocaine and oral anticoagulants. Avoidance of the combination or a reduction in dosage may be necessary. ADVERSE EFFECTS: Diarrhoea, dizziness, rash, tiredness, gynaecomastia, occasional reversible liver damage, confusion, very rarely intestinal nephritis, acute pancreatitis, thrombocytopenia, headache, myalgia, arthralgia. DOSAGE & ADMINISTRATION: By mouth 400 mg twice daily at breakfast and bedtime or 200 mg 3 times daily with meals and 400 mg at bed time. (1g/day) Acute Treatment: 800 mg at bed time. Duration of therapy is 4 weeks (6 weeks in benign gastric ulceration). Maintenance therapy 400 mg at bed time. Persistent acid - related dyspeptic symptoms 400 mg twice daily for 4 times daily with meals and at bed time. Zollinger - Ellison syndrome and other hypersecretory conditions 1.6g or more daily in divided doses. SYMPTOMS OF OVERDOSAGE AND ANTIDOTE: Symptoms of overdose include: High pulse rate, dilated pupils, speech disturbances, agitation and disorientation. Treatment for overdosage by cimetidine include: Emptying the stomach for example by lavage, provided not more than 4 hours have elapsed since the incidence occurred, supportive measures and symptomatic treatment may be sufficient in most cases. STORAGE/HANDLING RECOMMENDATIONS: STORE IN A COOL DRY PLACE AWAY FROM LIGHT.
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